Unlike the situation for new drugs, it is not necessary to conduct clinical trials for every new medical device before it is approved and marketed. This depends on the device classification. Although each country or region defines the device classification in somewhat different ways, they each...
There is a clear description in GCP regarding requirement for accountability of investigational medicinal products such as: 4.6.1: Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. 4.6.3 The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution,...
